(33 days)
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation and other positive pressure breathing assistance. The Aeroneb Pro is suitable for use in adult and pediatric patients as described in the Instruction Manual.
The Aeroneb® Professional Nebulizer System is a multiple patient reusable pulmonary drug delivery system that incorporates Aerogen's proprietary aerosol generator technology for continuous nebulization of drugs to patients. The Aeroneb Pro is designed to be used with mechanical ventilators and pressurized breathing systems as well as by spontaneously breathing patients. It is intended for multiple patient use and is autoclavable. The nebulizer can be placed in the inspiratory limb of a ventilator circuit or used with a mask or mouthpiece. The Aeroneb Pro operates without changing patient ventilatory parameters, can be refilled without interrupting ventilation, and can be powered by AC/DC adapter or internal rechargeable battery. Because the Aeroneb Pro operates without compressed gas and can be battery-powered, it is also suitable for use during patient transport.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aeroneb® Professional Nebulizer System, structured to answer your questions.
Device: Aeroneb® Professional Nebulizer System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance within design parameters (safety and effectiveness) | "demonstrated the device consistently performed within its design parameters" |
| As safe and effective as predicate devices | "is as safe and effective, and performs as well as, or better than, the predicate devices" |
| Conformance to FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS (Oct 1, 1993) | "Evaluation of performance included nebulizer delivery characterization, electrical, mechanical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE..." |
| Substantial equivalence to predicate devices | "The Aeroneb Pro is substantially equivalent to similar features in the predicate devices and has the same intended use and technological characteristics as the predicate devices." |
Note: The provided text outlines performance evaluations rather than specific, quantifiable acceptance criteria with numerical targets. The "acceptance criteria" are implied to be achieving performance that is at least as good as, and preferably better than, the predicate devices, while adhering to relevant FDA guidance and design parameters.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature). It only mentions "Non-clinical performance tests were conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention human experts or ground truth establishment in the context of device performance testing. The "performance evaluations" described are non-clinical, focusing on the device's physical and functional characteristics rather than an assessment of human interpretation or diagnosis.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. This is expected as the evaluations were non-clinical performance tests, not human-in-the-loop assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance evaluations were non-clinical and focused on the device itself, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, a standalone performance evaluation was done. The described "Performance evaluations" (nebulizer delivery characterization, electrical, mechanical, and EMC safety) are all assessments of the device's inherent performance, independent of human interaction or interpretation beyond its operation. The device itself is not an AI algorithm, but the evaluation methods used are analogous to a standalone performance assessment for a physical medical device.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations was based on engineering and performance metrics related to nebulization delivery, electrical and mechanical safety, and electromagnetic compatibility (EMC). This would involve:
- Measurement of physical parameters: e.g., aerosol particle size, drug delivery rate, power consumption, mechanical integrity.
- Compliance with standards: e.g., electrical safety standards, EMC standards.
- Comparison to predicate device performance: Using the established performance of the predicate devices as a benchmark for "as safe and effective" or "better than."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device and its evaluation. This is a physical medical device, not an AI or machine learning algorithm that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this physical device, this question is not applicable.
{0}------------------------------------------------
Section 2 Aeroneb® Professional Nebulizer System 510(k) Premarket Notification
SMDA 510(k) Summary of Safety and Effectiveness
(1) Submitter's name / Contact person:
Aerogen Inc. 1310 Orleans Drive Sunnyvale, CA 94089
Contact person:
Traci V. A. Edwards Senior Director, Quality Assurance & Regulatory Affairs Tel .: (408) 543-2414 Fax: (408) 543-2450
Date prepared:
March 2002
(2) Name of device:
Trade name:
Common name: Classification name: Aeroneb® Professional Nebulizer System (Aeroneb Pro) Nebulizer Nebulizer, 21 CFR §868.5630
(3) Identification of predicate device:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Aerogen Inc. | Aeroneb® Portable Nebulizer System | K970010/ K003022 |
| Siemens-Elena AB | Siemens Servo Ultra Nebulizer (SUN),Models 354 and 145 | K960854 |
(4) Description of the device:
The Aeroneb® Professional Nebulizer System is a multiple patient reusable pulmonary drug delivery system that incorporates Aerogen's proprietary aerosol generator technology for continuous nebulization of drugs to patients. The Aeroneb Pro is designed to be used with mechanical ventilators and pressurized breathing systems as well as by spontaneously breathing patients. It is intended for multiple patient use and is autoclavable. The nebulizer can be placed in the inspiratory limb of a ventilator circuit or used with a mask or mouthpiece. The Aeroneb Pro operates without changing patient ventilatory parameters, can be refilled without interrupting ventilation, and can be powered by AC/DC adapter or internal rechargeable battery. Because the Aeroneb Pro operates without compressed gas and can be battery-powered, it is also suitable for use during patient transport.
(5) A statement of the intended use of the device:
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation and other positive pressure
{1}------------------------------------------------
breathing assistance. The Aeroneb Pro is suitable for use in adult and pediatric patients as described in the Instruction Manual.
(6) Predicate device comparison:
The Aeroneb Pro is substantially equivalent to similar features in the predicate devices and has the same intended use and technological characteristics as the predicate devices.
Non-clinical performance tests were conducted comparing Aeroneb Pro to the Aeroneb Portable Nebulizer System and SUN 145.
(7) Performance evaluations
Evaluation of performance included nebulizer delivery characterization, electrical, mechanical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.
The successful tests demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Aerogen, Inc. c/o Mr. Mark Job TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K021175
Aeroneb® Professional Nebulizer System Regulation Number: 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II (two) Product Code: 73 CAF Dated: April 29, 2002 Received: April 30, 2002
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Tell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Section 1 Aerogen Aeroneb® Professional Nebulizer System 510(k) Premarket Notification
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Aeroneb® Professional Nebulizer System
Indications for Use:
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple p The Aeroned "Professional Nebalizer "System".o a prescribed solutions for inhalation to
patient use that is intended to aerosolize physician-prescribed solutions on The patient use that is mended to acrooolize prifer positive pressure breathing assistance. The patients on and on ventuation of other on adult and perficants and peditable patients as described in the Instruction Manual.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANTOHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Cardiova iratory Des (k) Number
Prescription Use_ (Per 21 CFR 801.109) OR
Over the Counter Use_
Optional Format 1-2-96)
SK25 AN
II
0/300/нчор.
CONFIDENTIAL
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).